A study published in the December 1st issue of The Spine Journal has found that there are a large number of inconsistencies between what physicians and companies report. The study, which was conducted by Rafael A. Buerba and colleagues at the Department of Orthopedics & Rehabilitation at the Yale University School of Medicine, got its participant pool from physicians who participated in the 2011 North American Spine Society (NASS); the researchers compared these disclosures to those reported on the Medtronic and DePuy Spine payment websites. The study reports 12.1 and 8.75 percent of NASS participants disclosed financial ties to Medtronic and DePuy Spine, respectively.
According to the researchers, the disclosure periods overlap and the numbers reported should have been comparable amongst the two sources. But this is not what the authors found. In fact, the study found that disclosures were inconsistent about half of the time. In fact, 54.2 percent of Medtronic’s disclosure were inaccurate, based on NASS disclosures. Based on DePuy Spine payment listings, there were discrepancies in 30 percent of participant disclosures.
The authors highlight the fact that financial relationships between doctors and industry can lead to a bias when it comes to research and decisions about health. The idea of financial transparency is of particular importance in the orthopedic and spine surgery. The study was conducted in anticipation of the Physicians Payment Sunshine Act (PPSA), a law that requires pharmaceutical other health-related companies to report any payment over $10 made to physicians. PPSA was passed in March 2010 and takes effect this year.
Medtronic Infuse is the primary recent example of why there needs to be complete transparency with financial ties. The product, which came onto the market in 2002, is used to help regrow bone in the spine. In June 2011, The Spine Journal published an entire issue dedicated to Infuse; a group of experts publicly denounced the product and the suspicious financial ties among Medtronic-paid authors. They found that the Medtronic-funded studies failed to mention side effects associated with Infuse, including cancer, male sterility, infections, bone dissolution and increased back and leg pain. According to the Spine Journal researchers, these complications occurred in 10 to 50 percent of patients who received Infused in clinical trials funded by Medtronic.
Even more condemning for Medtronic, a subsequent government investigation found that the Medtronic-funded studies were biased. A report by the United States Senate Finance Committee found that Medtronic employees helped write and edit 11 out of 13 studies.